A Study to Evaluate a Single Intramuscular Dose of Motavizumab to Treat Children With Respiratory Syncytial Virus (RSV) Illness

MedImmune

Status and phase

Terminated

Phase 2

Conditions

Participants Less Than 12 Months of Age With RSV Illness

Treatments

Other: Placebo

Biological: Motavizumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT00435227

MI-CP146

Details and patient eligibility

About

This was a Phase 2, randomized, double-blind, placebo-controlled, multicenter study to determine the effect of a single 30 mg/kg intramuscular (IM) dose of motavizumab on viral load and motavizumab levels in the upper respiratory tract of children who present with RSV illness but who do not require hospitalization. Using 1:1 randomization, 30 mg/kg motavizumab or placebo will be administered as soon as possible after a child's diagnosis of RSV and his/her eligibility for the study has been confirmed.

Full description

This was a Phase 2, randomized, double-blind, placebo-controlled, multicenter study to determine the effect of a single 30 mg/kg IM dose of motavizumab on viral load in the upper respiratory tract of children who present with RSV illness but who do not require hospitalization. Participants were randomly assigned in a 1:1 ratio to 30 mg/kg motavizumab or placebo as soon as possible after a child's diagnosis of RSV and his/her eligibility for the study had been confirmed. Randomization was stratified by age (<6 months and greater than or equal to 6 to less than or equal to 12 months of age) and by site. Enrollment of an initial 100 children (50 per treatment group) will take place at multiple sites beginning in the 2006-2007 RSV season. The study was terminated early due to inability to enroll the planned number of participants.

Enrollment

12 patients

Sex

All

Ages

Under 12 months old

Volunteers

No Healthy Volunteers

Inclusion criteria

Previously healthy
Age ≤12 months at the time of randomization
Weight ≤10 kg at the time of randomization
Gestational age ≥36 weeks
RSV illness (must have coryza) documented by a positive RSV test at the time of evaluation
Documented stable clinical condition that does not require hospitalization (oxygen saturation ≥ 95%; respiratory rate < 60 breaths/minute in children < 2 months and < 50 breaths/minute in children 2-12 months)
Respiratory Distress Assessment Instrument (RDAI) score of ≤ 6 (there can be no more than 1 point assigned for each of the 6 assessment categories) at baseline evaluation
Randomization within 4 hours of being evaluated with a positive Binax® RSV test
Written informed consent obtained from the participant's parent(s) or legal guardian

Exclusion criteria

Prior receipt of or receiving treatment with steroids (except topical steroids) prior to randomization
Prior medically diagnosed RSV infection
Prior receipt of or receiving anti-viral treatment for the current episode of RSV infection prior to randomization
Any medically significant underlying ongoing chronic illness or organ system dysfunction or other known acute illness, other than the acute RSV infection
Known renal impairment, hepatic dysfunction, hematologic abnormalities, seizure or other neurologic disorder or immunodeficiency
Requirement for supplemental oxygen (brief use of oxygen in the immediate postnatal period to treat a transient condition is allowed)
Mechanical ventilation at any time prior to the onset of the current RSV infection
Congenital heart disease [children with medically or surgically closed patent ductus arteriosus (PDA), small atrial septal defect (ASD) or small ventricular septal defect (VSD) will be allowed]
Previous reaction to intravenous immunoglobulin (IVIG), blood products, or other foreign proteins
Prior use of IVIG, RSV-IGIV (RespiGam®), motavizumab or other immunoglobulin products within the past 2 months
Prior use of palivizumab (Synagis®) within the past 2 months
Currently receiving other investigational agents or have received any other investigational agents within the last 3 months
Prior or current participation in any investigational study with a therapeutic agent or vaccine for RSV